FDA 510(k) Application Details - K033950

Device Classification Name	Lens, Contact, Polymethylmethacrylate, Diagnostic   More FDA Info for this Device
510(K) Number	K033950
Device Name	Lens, Contact, Polymethylmethacrylate, Diagnostic
Applicant	DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.) ONE LITTLE RIVER ROAD KINGSTON, NH 03848 US Other 510(k) Applications for this Company
Contact	FRAN CARLETON Other 510(k) Applications for this Contact
Regulation Number	886.1385   More FDA Info for this Regulation Number
Classification Product Code	HJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2003
Decision Date	02/20/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review